Novel opioids that protect against oral overdose and disrupt the progression to misuse, abuse, and addiction

新型阿片类药物可防止口服过量并阻止误用、滥用和成瘾的进展

基本信息

批准号：
9534356
负责人：
Thomas E Jenkins
金额：
$ 284.18万
依托单位：
ELYSIUM THERAPEUTICS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-06-15 至 2021-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9534356
关键词：
Address American Biological Assay Canis familiaris Chemistry Chromosome abnormality Clinical Clinical Research Development Dosage Forms Dose Epidemic Evaluation Fright Goals Government Grant Heroin Dependence Human Hydrocodone Lead Licensing Manufactured Materials Medicine Naltrexone National Institute of Drug Abuse Opioid Opioid agonist Oral Overdose Pain management Patient Care Patients Percocet Persons Pharmaceutical Preparations Pharmacologic Substance Phase Powder dose form Prescription opioid overdose Process Prodrugs Qualifying Rattus Resistance Risk Route Safety Societies Technology Therapeutic Equivalency Tissues Toxicokinetics Toxicology United States United States National Institutes of Health Vicodin Work addiction analytical method attenuation base commercialization design first-in-human genotoxicity heroin use human study in vivo individual patient innovation interest new technology novel opioid epidemic overdose death pain relief pill prescription drug abuse prescription opioid prescription opioid abuse process optimization programs research and development scale up

项目摘要

Project(Summary(/(Abstract( The abuse of prescription drugs is the fastest-growing drug problem in the United States, and reducing such abuse is a national priority. In 2014, prescription opioids caused 18,893 overdose deaths in the United States, according to the American Society of Addiction Medicine. The best way to defeat an epidemic is to reduce exposure. In this case, the challenge is to reduce exposure without compromising patient care. This calls for a balanced solution that addresses both the individual patient's needs and the national opioid epidemic. Elysium’s O2P (oral overdose protection) technology is designed to provide such a balanced solution by taking advantage of the well-established efficacy of existing opioids, while protecting against abuse and fatal overdose. Using novel chemistry, we have created a new class of immediate-release (IR) oral opioids that offer an attractive alternative to the widely-prescribed Vicodin®, Percocet®, Lortab®, Norco®, etc. with superior tamper resistance and unprecedented protection from oral overdose that could: · Save thousands of lives each year; · Disrupt the heartbreaking and often lethal progression from the misuse and abuse of prescription opioids, to heroin use and addiction; and · Provide safe pain relief to patients throughout the world that currently do not have access to effective opioid-based pain therapy due to fears relating to abuse and overdose. With NIH and NIDA’s support (1R44DA037900), Elysium has successfully achieved in vivo proof-of-concept. The overall goal of this proposed grant is to collaborate with a Strategic Alliance of highly qualified CROs and scientific advisers to accelerate development of our O2P IR hydrocodone product candidate through Phase 1 human proof of concept studies, a pivotal step toward advancing our lead toward FDA approval, and a commercialization deal with a larger pharmaceutical company.

项目（摘要（/（摘要（滥用处方药是美国增长最快的毒品问题，减少此类滥用是 2014 年的国家优先事项。根据美国药物滥用协会的数据，美国有 18,893 人因服药过量死亡成瘾医学。战胜流行病的最佳方法是减少接触。在这种情况下，挑战是。在不影响患者护理的情况下减少暴露这需要一个平衡的解决方案。这既满足了患者个体的需求，又满足了全国阿片类药物流行的问题。 Elysium 的 O2P（口服过量保护）技术旨在提供这样的通过利用现有的既定功效来平衡解决方案阿片类药物，在防止滥用和致命过量的同时，我们使用新型化学物质。创造了一种新的速释 (IR) 口服阿片类药物，具有吸引力广泛使用的 Vicodin®、Percocet®、Lortab®、Norco® 等的替代品卓越的防篡改能力和前所未有的防止口服过量的保护，可以： · 每年拯救数千人的生命； · 中断误用和误用导致的令人心碎且往往致命的进展滥用处方阿片类药物、吸食海洛因和成瘾；以及 · 为世界各地目前无法缓解疼痛的患者提供安全的疼痛缓解由于担心滥用，可以获得有效的基于阿片类药物的疼痛治疗和过量。在 NIH 和 NIDA 的支持下（1R44DA037900），Elysium 已成功实现 Vivo 概念验证。这项拟议拨款的总体目标是与高素质 CRO 和科学顾问的战略联盟将加速通过 1 期人体开发我们的 O2P IR 氢可酮候选产品概念验证研究，这是推动我们获得 FDA 批准的关键一步，并与一家更大的制药公司达成商业化协议。